SOFTMATE SOLUTION

FDA Premarket Approval N18073 S022

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceSOFTMATE SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1990-11-21
Decision Date1994-04-13
PMAN18073
SupplementS022
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
N18073Original Filing
S024 1995-01-27 Normal 180 Day Track
S023 1992-10-26 Normal 180 Day Track
S022 1990-11-21 Normal 180 Day Track
S021
S020 1990-03-27 Normal 180 Day Track
S019 1990-01-30 Normal 180 Day Track
S018 1989-10-13 Normal 180 Day Track
S017 1987-11-30 Normal 180 Day Track
S016
S015 1987-01-29 Normal 180 Day Track
S014 1986-11-07 30-Day Supplement
S013 1986-11-06 30-Day Supplement
S012 1986-09-18 Normal 180 Day Track
S011 1986-09-02 Normal 180 Day Track
S010
S009 1986-06-11 Normal 180 Day Track
S008 1985-08-12
S007 1985-08-12
S006 1985-04-08
S005
S004 1983-06-07
S003 1982-04-13
S002 1980-02-05
S001 1979-06-23

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